Hypervolemic and Euvolemic Hyponatremia
Conditions
Brief summary
This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011\ 31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.
Detailed description
This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.
Interventions
None listed
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level \< 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction 2. Patients who are prescribed Samsca® treatment as per investigator's medical judgment 3. Patients who gave written authorization to use their personal and health data 4. Patients starting Samsca® treatment after agreement is in place Investigators will refer to the product market authorization (label) for inclusion criteria.
Exclusion criteria
* Subjects presenting with any of the following will not be included in the study: 1. Patients who have been treated with Samsca® 2. Patients with known or suspected hypersensitivity to tolvaptan or to any ingredient of the drug 3. Patients requiring urgent intervention to raise serum sodium acutely. 4. Inability of the patient to sense or appropriately respond to thirst. 5. Hypovolemic hyponatremia 6. Concomitant use of strong CYP3A inhibitors 7. Anuric patients 8. Volume depletion patients 9. Hypernatremia patients 10. Women who are pregnant or possibly pregnant and lactation 11. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Investigators will refer to the product market authorization (label) for
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Measure | 4days | Adverse Events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit | Follow-up at least 4 days after first Samsca® dose | In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Safety Set all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen | 668 |
| Total | 668 |
Baseline characteristics
| Characteristic | Safety Set | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 514 Participants | — |
| Age, Categorical Between 18 and 65 years | 154 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 326 Participants | — |
| Sex: Female, Male Male | 342 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 668 |
| other Total, other adverse events | 110 / 668 |
| serious Total, serious adverse events | 10 / 668 |
Outcome results
Primary
Safety Measure
Adverse Events (AEs)
Time frame: 4days
Population: Safety analysis set was defined as all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Safety Set | Safety Measure | 17.37 percentage of AE |
Secondary
Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit
In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit
Time frame: Follow-up at least 4 days after first Samsca® dose
Population: the efficacy set is patients who received Samsca® tablets for at least 4 consecutive days and had the data on serum sodium level(mEq/L) on the 4th day of receiving Samsca® tablets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Safety Set | Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit | Firtst visit | 123.78 mean change of serum sodium level(mEq/L) | Standard Deviation 4.81 |
| Safety Set | Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit | 4th day | 134.83 mean change of serum sodium level(mEq/L) | Standard Deviation 5.69 |